Advanced wound site management systems and methods

ABSTRACT

An introducer comprises a sheath, a guide rod, at least one wire stabilization guide, and a loop actuation wire for locating within a wound opening during a medical procedure and during closure of the wound. The elongated members may be actuated to form a loop, or the wire stabilization guides may be adapted loop actuation wire is threaded into the slot and comprises at least a first end and a loop portion. The first end is slidably disposed through the wire stabilization guide, and the loop portion is disposed so that, when the sheath is approximated to a wound site, the loop portion is approximated to tissue surrounding the wound site to hold the sheath approximately centered on the wound site. A method for identifying the depth of insertion of a transluminal device into an artery or vein based on the presence of pressurized blood internal to the vessel and the absence of pressurized blood external to the vessel is also provided.

CROSS-REFERENCE TO RELATED APPLICATION

The present invention is a continuation-in-part of application Ser. No.09/658,786, filed Sep. 11, 2000, now U.S. Pat. No. 6,322,580 whichclaims benefit of Ser. No. 60/230,234 filed Sep. 1, 2000 and assigned tothe same assignee.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a wound site management, for use duringand after an invasive medical procedure. More specifically, the presentinvention relates to wound site management techniques and methodologyfor diagnostic and interventional procedures occurring at a wound site,for example, a puncture made in the wall of an artery or vein during amedical procedure. The puncture may be the result of a catheter-basedintervention, although any puncture is contemplated, accidental orintentional. The present invention has particular utility for use in andaround the femoral, radial, and brachial arteries after coronary/cardiacprocedures. Other utilities include soft-tissue anchoring, tendon andartery joining, meniscal repair, thoracic lung closure, heart repair,endoscopic procedures, esophageal repair, laparoscopy, skin/epidermalwound closure and general tissue closure.

2. Description of Related Art

Catheters/catheterization procedures are well known, and typicallyinvolve insertions through the femoral artery for diagnosis or to treatcardiovascular and /or peripheral vascular diseases. After a diagnosticor interventional catheterization, the puncture formed by the cathetermust be closed. The puncture opening in the artery typically ranges from5F for a diagnostic procedure to 6-10F for an interventional procedure.Traditionally, intense pressure has been applied to the puncture sitefor at least 30-45 minutes after removal of the catheter. Otherapproaches include a thrombotic or collagen plug, and/or other suturingmethodology for sealing the puncture. Patients who have had a femoralpuncture are then required to remain at bed rest, essentially motionlessand often with a heavy sandbag placed on their upper legs, for severalhours to ensure that the bleeding has stopped. This traditional methodof hemostasis following femoral artery access has many inadequacies.When a blockage is removed during a procedure, the patient quickly feelsbetter and they often have more energy than they have had in years, butthey must remain motionless for several hours. The weight of the sandbagon the femoral artery often causes the lower leg to tingle or go numb.The recovery time from the medical procedure may be as little as ½ hour,but the recovery time from the wound can exceed 24 hours. The longer therecovery time, the more expensive the procedure becomes, the greater thepatient discomfort, and the greater the risk of complications.

SUMMARY OF THE INVENTION

It will be appreciated by those skilled in the art that although thefollowing Detailed Description will proceed with reference being made topreferred embodiments, the present invention is not intended to belimited to these preferred embodiments. Other features and advantages ofthe present invention will become apparent as the following DetailedDescription proceeds, and upon reference to the Drawings, wherein likenumerals depict like parts, and wherein:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-3 are isometric views of one embodiment of the staple of thepresent invention in formed, opened and deployed positions,respectively;

FIG. 3A depicts an isometric view of alternative staple of theembodiment of FIGS. 1-3;

FIGS. 4-6 are isometric views of another embodiment of the staple of thepresent invention in formed, opened and deployed positions,respectively;

FIG. 7 depicts one embodiment of the stapler of the present invention;

FIG. 8 is an isometric view of the distal tip of the stapler of FIG. 7adapted to hold and deploy the staple of FIGS. 1-6;

FIGS. 9A-11B are isometric views of the cooperative movement of thedistal tip of the stapler and the staple of the present invention;

FIGS. 12-15 are isometric views of an exemplary staple deploymentmechanism of the stapler of the present invention;

FIGS. 16 and 17 are isometric views of another exemplary stapledeployment mechanism of the stapler of the present invention;

FIGS. 18-26 depict various views of procedural embodiments of thepresent invention, including FIG. 20 depicting one embodiment of theintroducer of the present invention;

FIGS. 27-34, 39, and 39A are isometric views of one exemplary embodimentof an introducer of the present invention;

FIGS. 35 and 36 are isometric views of another exemplary embodiment ofan introducer of the present invention;

FIGS. 37 and 38 are isometric views of blood marking passageways of theintroducer of the present invention;

FIGS. 40-45 depict another exemplary introduced of the presentinvention;

FIGS. 46-49 depict yet another exemplary introducer of the presentinvention; and

FIGS. 49-55 depict exemplary retention devices for the introducer of thepresent invention.

DETAILED DESCRIPTION OF THE INVENTION

Tissue Staple

In one aspect of the present invention, a staple is provided to close atissue wound after a medical procedure. Although the preferred use ofthe staple of the present invention is to close an artery or veinfollowing a diagnostic or interventional procedure, it should berecognized at the outset that the staple may be used for general tissuerepair, not just limited to vascular repair. It will be appreciatedthroughout the following description that the staple of the presentinvention can be formed of any biocompatible and/or bioabsorbablematerials, including, for example, Titanium (and Titanium alloys),stainless steel, polymeric materials (synthetic and/or natural),ceramic, etc. It will also be apparent from the following descriptionthat the staple of the present invention is preferably formed of adeformable material (such as those listed above) that undergoes plasticdeformation (i.e., deformation with negligible elastic component.) As ageneral overview, the staple of the present invention undergoes twopositions of deformation: a first position to extend the distal ends ofthe prongs of the staple outwardly to grab a greater amount of tissue(and also to grab tissue away from the wound locus), and a secondposition to move the prongs inwardly to close the wound.

FIGS. 1, 2 and 3 depict one embodiment of staple 10 of the presentinvention. FIG. 1 is the staple in it's formed position, FIG. 2 is thestaple just prior to deployment into tissue with the prongs extendedoutwardly, and FIG. 3 is the staple closed around tissue. The staple 10of this embodiment comprises a plurality of prongs 12A-12D and aplurality of tabs 14A-14D, arranged about a centerline axis 100. Commonportions, or shoulders 16A-16D are formed where the tabs meet theprongs. Each shoulder is common to both the prong and the tab and isgenerally defined by a relatively flat portion generally orthogonal tothe centerline axis. Shoulders 16A-16D may be viewed as an extension ofeach prong, bent inwardly toward the centerline axis. Each of thesefeatures of the staple 10 of this embodiment is detailed below. In theformed position (FIG. 1), prongs 12A-12D extend generally parallel tocentral axis 100, as shown. At the distal end of each prong, taperedpoints 18A-18D is formed to extend inwardly toward the centerline axis100. At the proximal end, shoulders 16A-16D meet at prongs 12A-12D,respectively. Tabs 14A-14D are generally U-shaped, and are formedbetween each prong. The proximal portions of each tab are joined atconsecutive shoulders, as shown. Each proximal portion of the U (i.e.,each “leg” of the U-shape tab) extends first generally outward from theshoulder, and second bends inwardly and distally toward centerline axis100, connecting together nearest the centerline axis to form the Ushape. The U-shape defines slots 20A-20D within each tab having a basepositioned at the bottom thereof.

Referring specifically to FIG. 2, the staple 10 is deformed so thatprongs 12A-12D extend outwardly from the centerline axis, prior todeployment into tissue. It is advantageous to extend the prongsoutwardly as shown so as to grasp a large portion of tissue, and so thatinsertion of the prongs into the tissue occurs at a locus away from thewound site, thereby providing a more consistent wound closure (byclosing the wound with more of the surrounding tissue) and ensuringcomplete (or near complete) closure of the wound. To deform the stapleinto the position shown in FIG. 2, a force F₁ is applied to tabs14A-14D, as shown in relief in FIG. 2A. Force F₁ is generally outward(from the centerline axis) and proximal to the top of the staple, asshown in relief in FIG. 2A. This force causes the tabs to move outwardfrom the centerline axis 100. The outward movement of the tabs causesthe shoulder portions to pivot roughly about the juncture between theshoulder and the prong (i.e., at the outer portion of the shoulder),causing the inner portions of the shoulders to move inwardly toward thecenterline axis and distally. Since the prongs are attached to the outerportion of the shoulders, the movement of the shoulders in this mannercauses the prongs to move outwardly. Thus, the cross-sectional diameterof the staple gets larger at the distal end (with respect to thecross-sectional diameter of the formed staple of FIG. 1). Note that themovement of the prongs is generally greater at the distal portionsthereof than at the proximal portions thereof. In other words, movementof the prongs as shown in FIG. 2 is pivoted from the shoulder, thusproducing a staple with outwardly extending prongs. For completeness, itshould be noted that a holding force may be applied downwardly (i.e.,substantially parallel to the centerline axis) against the base of theslots 20A-20D to hold the staple in place. Also, it is preferred thatthese forces are simultaneously applied to each tab of the staple toproduce uniform deformation of each prong of the staple. As mentionedabove, it is preferable that the plastic deformation of the staple issemi-permanent, so that the staple does not tend to return to the shapedepicted in FIG. 1 (i.e.,non-elastic deformation). Deformation of thestaple into this position will be described in greater detail below inreference to the preferred stapler device of the present invention.

FIG. 3 depicts the staple 10 in a closed position. The closed position,as stated herein generally means that the prongs of the staple are movedinwardly toward each other. Although FIG. 3 depicts the tapered tipportions of the prongs meeting generally in the vicinity of thecenterline axis, however, it should be understood that the term “closed”or “deployed” as used in reference to the staple need not necessarilymean this precise configuration. It may be required (or desirable) forsome procedures to move the prongs inwardly toward each other to agreater or lesser extent than as depicted in FIG. 3. To draw the stapleinto the closed position depicted in this Figure, a force F₃ is appliedto the inner surfaces 30A-30D of the shoulders. This force is generallyorthogonal to the centerline axis, and the angle between each forceapproximates the angle between the inner surfaces 30A-30D (which, in thestaple of this embodiment is approximately 90 degrees). This forcecauses the slots 20A-20D to spread apart and urges the shouldersoutwardly. Movement in this manner also causes the shoulders to moveoutwardly and proximally. Proximal movement of the shoulders causes theprongs to move toward each other. Opposite to the movement of FIG. 2,deformation shown in FIG. 3 results in an expanded cross-sectionaldiameter of the proximal end of staple, and a diminished cross-sectionaldiameter of the distal end of the staple (with respect to the formedstaple of FIG. 1 and the deformed staple of FIG. 2). Again, deformationof the staple 10 into this position will be described in greater detailbelow in reference to the preferred stapler device of the presentinvention.

For certain tissue application, it may be desirable that the staple ofthe present invention is deployed into tissue such that the prongs donot fully pierce through the tissue, but rather grasp and hold thetissue together. For example, for vascular closure applications it maybe desirable that the tissue piercing tapered ends not enter thebloodstream, but rather pierce into the tissue and stop short ofpiercing through the tissue wall. To that end, and referring to FIG. 3A,the staple 10′ of the present invention can be adapted with tissue stops32A-32D. Preferably, tissue stops 32A-32D are located along the lengthof each prong, and positioned from the distal tip of the prong to permitthe tapered ends to pierce tissue, but not pierce all the way throughthe tissue. Accordingly, the position of the stops 32A-32D along thelength of the prongs is selected to facilitate tissue grabbing (but notcomplete tissue piercing) and can vary from application to application.

FIGS. 4-6 depict another embodiment of a staple 50 of the presentinvention. FIG. 4 is the staple in it's formed position, FIG. 5 is thestaple just prior to deployment into tissue with the prongs extendedoutwardly, and FIG. 6 is the staple closed around tissue. Similar to thefirst embodiment, the staple 50 of this embodiment comprises a pluralityof prongs 52A-52D arranged about a centerline axis 100. A shoulder56A-56D is provided and is generally defined by a relatively flatsurface, generally orthogonal to centerline axis. Shoulders 56A-56D maybe viewed as an extension of each prong, bent inwardly toward thecenterline axis. In this embodiment, webs 54A-54D are connected to andbetween each prong, and are formed to extend inwardly from each prongtoward the centerline axis, creating a U shape generally orthogonal tothe centerline axis (as opposed to the previous embodiment in which theU-shaped tab is positioned generally parallel to the centerline axis).Each of the features of the staple 50 of this embodiment is detailedbelow.

In the formed position (FIG. 4), prongs 52A-52D extend generallyparallel to central axis 100, as shown. At the distal end of each prong,tapered points 58A-58D are formed to extend inwardly toward thecenterline axis 100. At the proximal end, shoulders 56A-56D meet atprongs 52A-52D, respectively. Web portions (webs) 54A-54D are generallyU-shaped, and are formed between each prong extending inwardly towardthe centerline axis. As shown, webs connect the prongs at a positiondistal to the shoulders. The precise position of the webs is determinedby the desired extent to which the prongs are extended outwardly, andthe extent to which the web curves inward toward the centerline axis.The space between the shoulders and the web portions defines a slot60A-60D.

Referring specifically to FIG. 5, the staple 50 is deformed so thatprongs 52A-52D extend outwardly from the centerline axis, prior todeployment into tissue. As with the previous embodiment, it isadvantageous to extend the prongs outwardly as shown so as to grasp alarge portion of tissue, and so that insertion of the prongs into thetissue occurs at a locus away from the wound site, thereby providing amore consistent wound closure (by closing the wound with more of thesurrounding tissue) and ensuring complete (or near complete) closure ofthe wound. To deform the staple into the position shown in FIG. 5, aforce F₁ is applied to webs 54A-54D, as shown in relief in FIG. 5A.Force F₁ is generally outward from the centerline axis and causes thewebs to deform outwardly, i.e. straightening the bend of the web bymoving the centermost point of the web outwardly. By deformation of theweb portions in this manner, the prongs move outwardly. Thus, thecross-sectional diameter of the staple gets larger at the distal end(with respect to the cross-sectional diameter of the formed staple ofFIG. 4). Note that the movement of the prongs is generally greater atthe distal portions thereof than at the proximal portions thereof, thusproducing a staple with outwardly extending prongs. For completeness, itshould be noted that a holding force may be applied downwardly (i.e.,substantially parallel to the centerline axis) against the top of thewebs in slots 60A-60D to hold the staple in place. Also, it is preferredthat these forces are simultaneously applied to each web of the stapleto produce uniform deformation of each prong of the staple. As mentionedabove, it is preferable that the deformation of the staple is plastic,so that the staple does not tend to return to the shape depicted in FIG.4. Deformation of the staple into this position will be described ingreater detail below in reference to the preferred stapler device of thepresent invention.

FIG. 6 depicts the staple 50 in a closed or deployed position. Theclosed position, as stated herein generally means that the prongs of thestaple are moved inwardly toward each other. To draw the staple into theclosed position depicted in this Figure, a force F₃ is applied to theinner surfaces 62A-62D of the shoulders. This force is generallyorthogonal to the centerline axis, and the angle between each forceapproximates the angle between the inner surfaces 62A-62D about thecenterline axis (which, in the staple of this embodiment isapproximately 90 degrees). This force urges the shoulders outwardly.Note that shoulders can only extend outwardly as far as the web portionswill permit. Outward movement of the shoulders causes the prongs to movetoward each other, since, there is a general pivot about the webportions. Opposite to the movement of FIG. 5, deformation shown in FIG.6 results in an expanded cross-sectional diameter of the proximal end ofstaple, and a diminished cross-sectional diameter of the distal end ofthe staple (with respect to the formed staple of FIG. 4 and the deformedstaple of FIG. 5). Again, deformation of the staple 50 into thisposition will be described in greater detail below in reference to thepreferred stapler device of the present invention.

In either embodiment described above, it should be evident that althoughthe Figures depict four each of the prongs, tabs and shoulders, thisshould be only be considered exemplary. It may be desirable to adapt thestaple 10 or the staple 50 with more or fewer prongs, tabs and shouldersfor a given application. Also, it is not necessary that each prong isthe same length, or that each prong has the same overall dimensions. Inalternative embodiments, the entire staple, or selected portions thereofcan be alternatively fashioned from an elastic or shape memory (e.g.,nitinol, and/or other elastic materials, including for exampletemperature dependant shape memory materials) material therebypermitting elastic deformation from the a static closed position to anexpanded position and then elastically close about the wound. Also, theembodiment of FIGS. 4-6 can be adapted with a tissue stop positionedalong the length of the prong, as shown in FIG. 3A.

Stapler Device

Another aspect of the present invention is a stapler device to deploythe staple 10 of FIGS. 1-3, the staple 10′ of FIG. 3A, and the staple 50of FIGS. 4-6. As a general overview, the stapler of the presentinvention includes a distal tip for holding and deploying a staple, andan actuator mechanism to cause a staple, or at least the tissue piercingportions of a staple, to expand outwardly and then close about a wound.The stapler of the present invention facilitates one object of thepresent invention to ensure that the staple closes a greater amount oftissue as compared with conventional stapling mechanisms. The followingdescription will detail various exemplary mechanisms to accomplish thisgoal, but it should be recognized that numerous alternatives will bereadily apparent to those skilled in the art, and all such alternativesare to accomplish these objectives are deemed within the scope of thepresent invention.

FIG. 7 depicts an isometric view of one embodiment of a stapling device100 of the present invention. The device generally includes an actuationmechanism 104 and a distal tip 102. FIG. 8 is a more detailed view ofthe distal tip 102 of the stapler device 200. The distal tip preferablycomprises an inner rod member 110 slidable within an outer sleeve 112.Rod 110 includes a flared or mandrel portion 114. Mandrel 114 alsoincludes slots 118A-118D, which in use are aligned with fingers116A-116D. Fingers 116A-116D mate with slots 20A-20D and 60A-60D of thestaple 10 and 50, respectively. Preferably, rod 110 is removable forstaple attachment thereto, where a staple is positioned between themandrel and the sleeve. The mandrel, as will be described below, isresponsible for the forces generated on the staple.

FIGS. 9, 10A, 10B, 11A and 11B depict the working relationship betweenthe staple 10′ and/or 50 of the present invention and the mandrel114/sleeve 112 of the stapler mechanism 200. In FIG. 9A, the staple 10′is placed between the mandrel 114 and sleeve 112. Slots 20A-20D of thestaple engage fingers 116A-116D of the sleeve. The prongs 12A-12D of thestaple are dimensioned so as to fit over the mandrel, and tabs 14A-14Dare dimensioned so as to fit over the rod 110, as shown. Similarly, forthe staple 50 shown in FIG. 9B the staple 50 engages the mandrel 114 andsleeve 112 (not shown). This is a static position, as no forces areapplied to the staple to cause deformation. In FIG. 10A, the staple 10′is urged into the first deformed position (of FIG. 2) by the relativemovement of the rod/mandrel and the sleeve. As shown, the mandrel isurged proximally. As the mandrel moves, the tabs of the staple meet thenarrowest part of the mandrel. Further movement forces the tabs to moveoutwardly, causing the prongs to likewise move outwardly (as describedabove with reference to FIG. 2). Once the tabs clear the mandrel,outward movement of the tabs and prongs ceases. Similarly, in FIG. 10B,the movement of the mandrel forces webs to extend outwardly causing theprongs to extend outwardly (as described above with reference to FIG.5). Once the webs clear the mandrel, outward movement of the prongsceases. FIG. 11A depicts final deployment of the staple into tissue. Asthe mandrel is drawn further proximally and once the tabs have clearedthe mandrel, the shoulders (not shown) are spread outward, forcing theprongs to move together (toward the centerline axis) and closing tissuetherebetween. FIG. 11B depicts the same actuation, but for the staple 50of FIGS. 4-6.

FIGS. 12-15 depict an exemplary actuator mechanism 104, showing therelative motion of the sleeve 112 and the mandrel rod 110. The mechanismincludes a cam 408 movable in a linear motion along a slot 412. Movementof the cam can be manual or through an electronically controllable motor(not shown). The cam 408 has lobes 408A and 408C located on a first sideof the cam 408 and a lobe 408B located on a second and opposing side ofthe cam 408. A first cam follower 418 is coupled to the mandrel rod 110,and is selectably engagable with lobes 408A and 408C. A second camfollower 416 is coupled to the sleeve 112, and is selectably engagablewith lobe 408B. FIG. 12 depicts that neither cam follower is in contactwith the lobes, and is indicative of an initial position of themechanism.

FIG. 13 depicts the mechanism 104 in a position to expand the staplebetween the mandrel 114 and the sleeve 112, as shown in FIG. 9A. As cam408 is moved (as indicated by the arrow), lobe 408A urges cam follower418 along slot 426. The mandrel rod 110 is moved proximally, causing theprongs to extend outwardly (as shown in FIGS. 2 and 5) as a result ofthe force of the mandrel 114 on the tabs or the web portions. Withfurther movement of the cam 408 (FIG. 14), lobe 408B now urges camfollower 416 to move distally, thereby moving the sleeve distallyrelative to the mandrel rod and causing further expansion of the prongsand causing the staple to move distally. Finally, in FIG. 15, the cam isurged yet further and cam follower 418 is urged by lobe 408C causing themandrel and madrel rod to extend further proximally. This relativemovement between the cam rod and the sleeve causes the mandrel to applya force to the shoulder portions of the staple, in turn causing inwardmovement of the prongs. Lobe 408C causes closure of the prongs anddecouples the staple from the mandrel. This is the fully deployed staplemovement.

FIGS. 16 and 17 show an alternative cam mechanism. Similar to theprevious example, cam 608 is urged in a direction indicated by the arrowto cause relative motion between the mandrel rod and the sleeve. Lobes608A and 608B are located on opposite sides of cam 608. As the cam 608is moved along slot 612, the lobe 608A urges a cam follower 618 in alinear motion along a slot 626. This urges the cam follower 618proximally. The cam follower 618 is coupled to a mandrel rod 604. Thisdeforms staple 10/50 in the second configuration (see FIG. 2 or 5). Asthe cam 608 is urged further, the cam follower 618 moves distally tostay in contact with the lobe 608A. This urges mandrel rod 604 distally.The same movement of the cam 608 urges lobe 608B to urge cam follower616 distally. The cam follower 616 is coupled to a sleeve 606. Thisurges sleeve 606 distally. The downward slope of lobe 608A is parallelwith upward slope of lobe 608B so the mandrel rod 604 and the sleeve 606move distally in unison and the staple is advanced into the tissue. Themovement of the cam follower 618 down the slope of lobe 608A then ceaseswhile the movement of cam follower 616 continues up the slope of lobe608B, the staple 10/50 is deformed into the closed or deployedconfiguration (see FIG. 3 or 6). Springs 614 and 650 can be provided toreturn cam followers 616 and 618, respectively, to an initial position.Of course an additional spring can be provided in slot 612 to move cam608 back to an original position.

Alternatively, the actuation mechanism can include a rotating drum (notshown) to replace the cam 408 and 612. The drum may be adapted withlobes formed thereon, similar to lobes 408A-408C and 608A-608B,respectively. Other alternatives may include a rotating screw having avariable width in accordance with lobes 408A-408C or 608A-608B toactuate the mandrel rod and/or sleeve. Of course, instead of the cammechanisms depicted in the Figures, direct linkage may be used toactuate the mandrel rod and/or sleeve.

Wound Site Management

FIGS. 18-25A depict structural and procedural embodiments of wound sitemanagement during and after a medical procedure, such as angioplasty.FIG. 18 depicts a conventional tubular dilator 500 extending through theskin of a patient. Typically, the dilator 500 is left in the skinfollowing a completed medical procedure. When the medical procedure hasbeen completed, the wound site must be stabilized. Although the bloodflow may not be completely stopped, the blood flow is reduced to a pointwhere the coagulants in the blood can complete the wound closure. Tostart the stabilization process of the wound site, the doctor inserts aflexible guide wire 502 through an opening 504 in the end of the dilator500. FIG. 19 shows the step of removing the introducer 500 from thewound site after the guide wire 502 is properly inserted through theskin and into the artery.

To facilitate efficient wound closure, another aspect of the presentinvention provides an introducer formed to stretch the wound site formore efficient and effective closure. FIG. 20 depicts an exemplaryintroducer 510 of the present invention, and continues the process fromFIGS. 18 and 19 where the introducer 510 slides over the guide wire 502through an opening in the introducer 510 and a portion of the introduceris placed into the artery. Details of the introducer 510 are disclosedbelow.

FIG. 20 depicts the introducer 510 inserted over the guide wire 502(already in the artery) and inserted into the artery. The introducerincludes a hollow elongated guide sheath 512 and dilator 520. Referringto FIG. 20A, the doctor urges the distal tip 516 of the dilator 520 intoand through the guide sheath 512 (over guide wire 502). A flexibledistal end 516 of the dilator 520 is inserted into the wound, until ablood marker BM indicates that the dilator 520 is properly positioned inthe artery. The blood marker BM located at a predetermined length alongthe dilator 520 allows blood to flow through a cavity 540 to alert thedoctor that the dilator 520, and more specifically the flexible distaltip 516, is properly inserted in an artery. Most preferable, the distaltip 516 of the dilator includes a tapered portion 522 to facilitateeasier ingress into the artery. An additional blood marking passageway(not shown) can be included on the distal end of sheath 512 asprecautionary indicator of the depth of the sheath. Presence of blood inthis additional passageway is indicative of the sheath being pressed toofar and into the arterial wall or into the artery. Of course, thoseskilled in the art will recognize that the introducer 510 will includeinternal passageways (lumens) for blood marking and the guide wire.

The diameter of distal end of the guide sheath 512 may be formed toexpand if outward pressure is applied from inside surface of the guidesheath 512. For example, slits or weakened tear seams (described below)may be formed in the distal end of the guide sheath 512 to allow thediameter of the guide sheath to increase when pressure is applied.

One feature of the guide sheath of this exemplary embodiment is the useof two or more wire guides 514 to maintain the sheath located on thewound site, to provide approximation of opposing sides of the wound, toensure that the closure device (e.g., stapler/staple, suturing device,cauterization, etc) remains located about the wound so that a closuredevice is properly deployed, and to provide unobstructed access to tilewound site. In this embodiment, wire guides 514 are formed on opposingsides of the guide 14 sheath 512. Having the wire guides 514 on opposingsides helps to ensure that not only is the sheath located on the woundsite, but that the sheath is approximately centered thereon. The wireguides are delivered into the artery by the dilator 520, as shown inFIGS. 21 and 26. The wire guides are removably coupled to the distal end516 of the dilator 520 and deployed into the wound, as shown in FIG. 26.The wire guides can be releasably held in openings or slots (not shown)on the sides of dilator. Once the dilator is properly inserted into thewound to a proper depth (as indicated by the BM passageway), the dilatoris removed from the wound and the guide sheath. To remove the dilator520 from the guide sheath 512, the doctor (or clinician) first holds theguide sheath 512 and advances the dilator 520 inward (and upward)through the guide sheath 512. This decouples the guide wires 514A and514B from the openings. To ensure that the wire guides 514A and 514Bproperly decouple from the dilator 520 before the dilator is withdrawn,a mechanism is provided that does not allow withdrawal until the guiderod has been inserted a predetermined distance. As shown in the drawingthis mechanism can include a hub mechanism that requires a twistingmotion or other action prior to withdrawal. After the guide rod has beeninserted the predetermined distance, the doctor extracts the guide rod.This leaves the guide sheath 512 centered on the wound with the wireguides 514A and 514B extending inside the wound.

As is understood to those skilled in the diagnostic and interventionalarts, a puncture in an artery or vein has a general tendency to manifesta slit or an elongated opening, since the cell structure forming thistissue forms circumferentially (rather than longitudinally) to supportradial expansion and contraction of the vessel. The wire guides 514A and514B of the present enable the wound to approximate the natural state ofthe wound, i.e., elongated circumferentially. The sheath may have adiameter approximately equal to the diameter of the opening or wound, sothat the distance between the wire guides 514A and 514B on the sides ofthe sheath approximately equals the diameter of the long axis of thewound, as best shown in FIG. 23. Once inside the vessel, the wire guides514A and 514B in this position limit movement of the sheath along thelong axis, and since the wound is elongated, movement along the shortaxis is likewise limited. In this embodiment, since the wire guides 514Aand 514B are disposed on opposing sides of the sheath, any deviceinserted through the sheath will be approximately centered on the wound.

Importantly, since the wound opening tends to assume the shape shown inFIG. 23 even in the absence of the wire guides, the opposing tissuelocated along the short axis tends to approximate. The present inventiontakes advantage of this tendency. If the position of the wire guidesdefine a diameter larger than the diameter of the wound, the tissuealong the short axis tends to approximate more, because the tissue onthe long axis is stretched, thereby creating tension on the wound site.In other words, in this configuration, the wire guides force the tissueon either side of the wound to come together. It will be appreciated bythose skilled in this art that the amount of tension required will betissue dependant, and thus, the overall diameter of the sheath and wireguides should be sized according to the wound size and tissue strength,and should not be sized to cause a tear in the tissue. For example,vascular tissue is relatively elastic, and can tolerate more tensionthan other tissues (e.g., dura-matter, duct tissue, bladder tissue,etc.). The sheath and dilator of the present invention take thesefactors into consideration and are accordingly sized for the particulartissue application. However, sufficient wound site management accordingto the present invention does not require that the wire guides stretchthe wound. Rather, if the position of the wire guides is shorter thanthe wound length, the wire guides still serve to maintain the sheathgenerally located (and possibly centered) on the wound. In bothcircumstances, the wire guides ensure that a closure (e.g., staple)deployment is more accurate. When tension is created on the wound site,a certain amount of tissue is available, which may be advantageouslygrasped by the staple for closure. Also, if the wound opening in thetissue is held taught by the sheath/wire guides, there is less tendencyfor the tissue surrounding the opening to slip down into the vesselduring staple deployment (which would reduce the effectiveness of theclosure).

FIG. 23 also shows examples of locations S1, S2, S3, and S4 of where theprongs of the staple to be inserted will line-up relative to the woundopening WO. The wire guides 514 are depicted disposed on opposing sidesof the guide sheath 512, and more specifically, the wire guides areinserted into the wound opening along the long axis of the artery orvein, so that the wound is pulled taught along the long axis.

FIG. 22 shows the distal end of a stapler 104 with a staple 10/50 beinginserted through the guide sheath 512 of the introducer 510. FIG. 22Adepicts a relief view of the introducer 510, and more clearly depictsthe slits or weakened tear seams 700. When the distal end of the stapler104 is properly inserted in the guide sheath 512, the staple can bedeployed into the tissue. FIG. 24 shows the first step of stapledeployment, the process of which is described in detail above. Note thatin FIG. 24A, the extension of the staple prongs causes the weakened tearseam or slits to separate. This further causes the wire guides to expandagainst the long axis of the wound, thereby further approximating thetissue surrounding the opening. The diameter formed by the prongs of thestaple 10/50 is now larger than the original outside diameter of theguide sheath 512. FIGS. 25 and 25A depict the staple fully deployed intotissue, the process of which is described above. The stapler can now beremoved from the guide sheath 512. The guide sheath 512 can now be urgedaway from the wound opening WO and the guide wires 514A and 514B areextracted from the closed opening.

In an alternative exemplary embodiment, instead of using wire guides, asingle loop actuation wire 654 is used, as in the exemplary introducerassembly 510′ illustrated in FIGS. 27-32. The exemplary introducerassembly 510′ is slidably disposed about a central guide wire 672 andcomprises a guide rod 670 and a guide sheath 662. The guide sheath 662includes a plurality of wire stabilization guides 660, which may beintegrated into the guide sheath 662, or alternatively, be formedseparately and coupled thereto. The wire stabilization guides 660generally comprise tubular members disposed around the outside diameterof the sheath, to hold the end portions 656, 657 of the loop actuationwire 654. Guide sheath 662 is a tubular and has a circularcross-sectional shape, and has an inside diameter dimensioned to slideover the guide rod 670. It is equally contemplated that the guide sheathhas an oval or non-circular cross-sectional shape. The sheath furtherincludes one or more slits or weakened tear seams 686 to providecontrolled expansion of portions of the guide sheath, as will bedetailed below.

The guide rod 670 is a tubular member and includes at least one slot 682formed therein for releasably holding the loop actuation wire 654. Asshown in FIG. 27, the guide rod has a main tubular body dimensioned tofit inside the guide sheath and has a tapered end 800 having an opening802 at the tip to accept the central guide wire. To releasably hold theactuation wire, at least one longitudinal slot 682 may be formed in theguide rod 670 along its length. To permit temporary holding andcontrolled release of the loop actuation wire 654, the width of thelongitudinal slot 682 at the surface of the guide rod 670 should be lessthan the outside diameter of the stabilization guides 660 or the loopactuation wire 654, so that the stabilization guide and/or loopactuation wire 654 is held within the slot (as shown in FIG. 27) untilreleased by the sliding action of the sheath over the guide rod, asdescribed below. The loop actuation wire and/or wire guides can be heldin a slot or slit formed in the guide rod (which may define a separatelumen structure in the guide rod), or alternatively the slot can beformed with a diameter less than the width of the wire or wirestabilization guide to permit the wire or wire stabilization guide tofriction fit into the slot. As shown in FIGS. 27-29, the slot 682 may bebounded by a pair of recessed areas 658, 659, so that, for example, thewire does not catch on tissue as the guide rod is inserted and removedfrom an artery or vein. Alternatively, instead of defined slots formedin the guide rod, slits (not shown) may be formed in the material of therod such that the loop actuation wire 654 is releasably held to theguide rod in a friction fit manner, and released from the guide rod in asimilar manner as described above.

In this configuration, one end portion 656 of the loop actuation wire654 is threaded inwardly into one end of the slot 682 at the firstrecessed area 658 and back outwardly from the slot 682 at the secondrecessed area 659 in the guide rod 670. Similarly, the other end portion657 of the loop actuation wire 654 may be threaded through a second slot(not shown), which may optionally include a set of recessed areas (notshown) on the opposing side of the guide rod 670, or elsewhere along itslength. The slot 682 may be located along the length of the guide rod670. For example, as shown in FIGS. 27-32, the slot 682 is located alonga line parallel to the central axis of the guide rod 670. Of course, itis not a requirement of the present invention that the slot be formed inthis manner, nor that the slot include recessed areas at its ends. Asused herein with reference to the location of the slot(s) 682 and/orrecessed areas 658, 659, the phrase “along the length of the guide rod”or “along its length” may mean generally longitudinally along thecentral axis of the guide rod, or may alternatively mean a slot formedin any orientation, since the slot and/or recessed areas 658, 659 merelyserve to releasably hold the wire stabilization guides 660 and/or ends656, 657 of the loop activation wire in place, and one of any number ofconfigurations of slot 682 and/or recessed areas 658, 659 may suffice.While not necessary to provide operability to the present invention, anopening 804 within the guide rod may be provide to expose a portion ofthe central guide wire 672. The central guide wire 672 can then beplaced over the loop portion 680 of the loop actuation wire 654 tosecure the loop to the guide rod until the central guide wire isremoved. The foregoing assumed that the wire forming the wire actuationloop has a generally circular cross section. However, alternativelyother wire shapes may be used, in which case the wire stabilizationguides 660 and slot 682 may comprise one or more internal matingcomponents adapted to mate with end portions 656, 657 of the loopactuation wire 654, in which case the end portions 656, 657 wouldcomprise one or more appropriate corresponding mating components.

FIGS. 39 and 39A depict cross-sectional views of the guide rod 670 ofthis exemplary embodiment. The guide rod 670, as depicted in FIG. 40,includes a plurality of lumens: 802, 804, 806 and 808. Lumens 808 and806 are included as a blood marking passageway (described above) and awire guide passageway, respectively. Lumens 806 and 808 are shownadjacent one another, but these lumens could also be formed coaxial withon another (e.g., the wire guide lumen inside of the blood markinglumen). Lumens 802 and 804 releasably hold the loop actuation wiretherein, and run along the length of the guide rod, for example, asshown in FIG. 27. Lumens 802 and 804 are shown on opposing sides of theguide rod. But it is equally contemplated that the lumens need not bedisposed at opposition, but rather may be formed at any angle withrespect to one another. A slit 810 may be provided such that the loopactuation wire is held in lumen 802/804 until outward pressure forcesthe wire to “pop” out of the slit 810. To that end, the materialsurrounding the slit may comprise material of reduced durometer (withrespect to the rest of the guide rod) such that the actuation wire canslide into and out of the lumen. Alternatively, instead of a slit, aslot may be formed as depicted in FIG. 40A. The slot 812 is defined bytruncated lobes 814 and 816. Lobes 814 and 816 may also comprisematerial of reduced durometer with respect to the remaining portions ofthe guide rod. Slot 812 can be dimensioned for a particular gage wireinserted therein. Although lumens 804 and 802 are depicted as havinggenerally circular cross-sectional shapes, the present invention equallycontemplates other shapes, as may be dictated by the cross-sectionalshape of the loop actuation wire (although the cross sectional shape ofthe wire stabilization guide, loop actuation wire and the lumen need notmatch).

The use of the foregoing described exemplary introducer 510′ will nowproceed with reference to FIGS. 27-32. As FIG. 27 illustrates, theintroducer 510′ is initially inserted into the percutaneous punctureover the central guide wire 672 (already in the artery), which tracksinto the puncture site, and is inserted into the artery. Once it hasbeen determined that the distal end of the guide sheath 662 has reachedthe approximate location of the artery or venous outer wall, the centralguide wire 672 may be removed from the introducer assembly 510′, asshown. As shown in FIG. 28, removing the central guide wire 672 allowsthe loop activation wire 654 to be freely released from the guide rod670 through the longitudinal apertures 682 within the guide rod 670.This is accomplished by withdrawing the guide rod 670 from the guidesheath 662 as shown in FIGS. 28 and 29. Removing the guide rod from theguide sheath forces the wire stabilization guides 660 (and the loopactivation wire within) out of the slots 682 defined in the guide rod byvirtue of the force of the end of the sheath on the wire stabilizationguides as the guide rod slides proximally out of the sheath, whereuponthe loop actuation wire 654 and wire stabilization guides 660 arereleased to form an open loop, as shown in FIG. 29. The guide rod 670may then be completely withdrawn from the guide sheath 662.

As FIGS. 30 and 31 illustrate, the stabilization guides 660 may besecured and actuated by pulling the loop actuation wire 654 at one orboth end portions 656, 657 until the distal ends of the stabilizationguides 660 approximate to form a stabilization loop portion 680.Preferably, slits 686 or weakened tear seams are formed in the distalend of the guide sheath 662 to allow the diameter of the guide sheath662 to increase when an outwardly radial force is applied to the distalend of the guide sheath 662, for example by the expansion of the loopportion of the loop actuation wire 654. The foregoing action providesopposing forces outwardly to the central axis of the guide sheath 662,thereby causing the end of the guide sheath 662 to separate at its slits686. Additional clearance for the expansion of a closure device (notshown) within the guide sheath 662 is thus provided. Furthermore, thetissue that is stretched by the stabilization guides 660 is caused toslide along the newly ramped angles of the stabilization guides 660 andbe forced against the distal end of the guide sheath 662. Moreover, theforegoing action aids in retaining the guide sheath 662 within thepuncture against the vessel. The closure modality (e.g., a staple, asdescribed hereinabove) may next be delivered. As shown in FIG. 32,tension may then be applied to a single end 657 of the loop actuationwire 654 until the wire 654 is completely removed from the plurality ofstabilization guides 660, thereby freeing the distal ends of thestabilization guides 660 and allowing them to slide out of the vesselpuncture on either side of the closure device (not shown). Finally, theguide sheath 662 assembly may be removed from the puncture site.

The wire stabilization guides 660A and 660B depicted in FIGS. 30-32 aregenerally formed as tubular structures having an inside diametersufficient to pass the wire ends 656, 657 therethrough. The guide 660Aand 660B are drawn together (FIG. 31) to form the loop. As a generalmatter, the wire stabilization guides 660A and 660B in combination withthe loop activation wire to the stiffness of the combined area, since itis intended that the closure of the guides causes sufficient outwardforce to expand the sheath along the slot or weakened tear seams, i.e.by creating a loop causing these outward forces. Note that the Figuresdepict wire guide 660A longer than 660B, however, it is not essentialthat the lengths of the wire guides are as depicted. Rather, the lengthsmay be selected to be equal or non-equal without departing from thepresent invention. The positions of the wire guides 660A and 660B aredepicted on opposing sides of the sheath. While this arrangement willprovide a more accurate centering of the sheath on the wound site, it iscontemplated herein that for certain procedures centering on the woundsite may not be necessary, critical, or accurate, and thus, thepositions of the wire stabilization guides can be at locations about thesheath other than at opposition.

Note also that the description of the slots in the guide rod toreleasably hold the wire stabilization guides are formed in a locationmost convenient for placing the wire guides into the slots. Also, theslots may be defined such that one slot releasably holds the wirestabilization guide with the wire inserted therethrough, and the otherslot is dimensioned to releasably hold just the wire (as may be the casewhen the lengths of the wire stabilization guides differ). Still othermodification may be made.

Thus, a single or multi-lumen sheath device may be stabilized in directapproximation to an arterial, venous or other lumenal puncture.Advantageously, the foregoing described method allows the positioning ofa closure modality directly centered over such a puncture. The foregoingdescribed introducer assembly 510′ allows the distal end of the sheath662 through which the closure device is introduced to be drawn againstthe artery, vein or other lumen, thereby aiding in sealing the puncturesite to prevent leakage, as well as stabilizing the sheath 662 directlyover the wound site.

As FIGS. 35 and 36 illustrate, in another embodiment, the foregoingdescribed stabilization loop portion may be replaced with astabilization loop portion 680′ comprising a loop actuation wire 654,and wire stabilization guides 660 having at least one reinforced section666. The reinforced section may comprise an area of increased materialor combination of materials, e.g., a section of the actuation wire 654or stabilization guide 660 with greater individual or combined rigidity.In this configuration, the location of the reinforced section 666 may bemanipulated with respect to the wound site to control the shape of thestabilization loop portion 680′. The stabilization guides 660 may besecured and actuated by pulling the loop actuation wire 654 at one orboth end portions 656, 657 until the distal ends of the stabilizationguides 660 approximate to form a stabilization loop portion 680′ whichcomprises the reinforced section 666, the central axis of which isgenerally perpendicular to the central axis of the guide sheath 662,thereby providing opposing forces outwardly perpendicular to the centralaxis of the guide sheath 662 and causing the end of the guide sheath 662to separate at its slits 686. As shown in FIG. 36, the loop portion andreinforced section forms a shape with the general appearance of coathanger. Additional clearance for the expansion of a closure device (notshown) within the guide sheath 662 may likewise be provided.

As in the previously described embodiment, the tissue which is stretchedby the stabilization guides 660 is caused to slide along the newlyramped angles of the stabilization guides 660 and be forced against thedistal end of the guide sheath 662. The foregoing action aids inretaining the guide sheath 662 within the puncture against the vessel.The closure modality (e.g., a staple, as described hereinabove) may nextbe delivered. As shown in FIG. 32, tension may then be applied to asingle end 657 of the loop actuation wire 654 until the wire 654 iscompletely removed from the plurality of stabilization guides 660,thereby freeing the distal ends of the stabilization guides 660 andallowing them to slide out of the vessel puncture on either side of theclosure device (not shown). Finally, the guide sheath 662 assembly maybe removed from the puncture site.

As those skilled in the art will recognize, it may be necessary for thedoctor to determine the point at which the distal end of the guidesheath 662 has reached the approximate location of the artery or venousouter wall prior to removing the central guide wire 672 from theintroducer assembly 510′. One exemplary method for identifying insertiondepth of a transluminal device will now be described with reference toFIGS. 33 and 34. As shown, two “flash back” blood marking lumens 689 arefixedly attached to the guide sheath 662. The distal end of the firstblood marking lumen is at an interluminal blood marking port 674 locatedat a predetermined point along the guide rod 670, and the proximal endof the first blood marking lumen is an interluminal flashback port 684for observing the presence of blood at the interluminal blood markingport 674. The distal end of the second blood marking lumen is anexraluminal blood marking port 675 located approximately at the distalend of the guide sheath 662, and the proximal end of the second bloodmarking lumen is an extraluminal flashback port 688 for observing thepresence of blood at the extraluminal blood marking port 675.

In operation, the introducer assembly 510′ is introduced into thepercutaneous puncture which tracks into the puncture site, as describedhereinabove. The location at which the guide sheath 662 has reached theapproximate location of the artery or venous outer wall may beidentified by observing the pressurized blood flow from the internalflashback port 684, which enters the internal blood marking port 674when the internal blood marking port 674 has reached the inner lumen ofthe vessel. The absence of pressurized blood flow observed at theinternal flashback port 684 indicates that the guide sheath 662 has notyet reached the vessel outer wall. The fact that the guide sheath 662has not entered the inner lumen of the vessel may be confirmed by theabsence of pressurized blood flow observed at the external flashbackport 688, which enters the extraluminal blood marking port 675 only ifthe extraluminal blood marking port 675 has reached the inner lumen ofthe vessel. Likewise, presence of blood in this lumen indicates theguide is too far into the artery or vein. The presence of pressurizedblood flow at the internal flashback port 684 and absence of pressurizedblood flow at the external flashback port 688 indicate that the distalend of the guide sheath 662 is adjacent to the arterial or venous outerwall.

FIGS. 37 and 38 depict alternative embodiments for bloodmarking. In FIG.37, the BM lumen 540 includes a sensor 700 (e.g., differential pressuretransducer, flow sensor, electrodes, etc.) to detect the presence offluid or fluid flow thereon. The wiring for the sensor can be routedthrough the lumen 540, as shown, to transmit a signal of the pressure(or presence of fluid) at the sensor 700. In FIG. 38, an optical fiber702 is placed in lumen 540 for direct viewing of the area around BMport.

Thus, the foregoing-described steps provide a method for identifying thedepth of insertion of the transluminal device into an artery or veinbased on the presence of pressurized blood internal to the vessel andthe absence of pressurized blood external to the vessel. Alternatively,more than two blood marking points, lumens, and ports may be provided tofurther aid in determining precisely the depth of the insertedtransluminal device. Furthermore, it is contemplated that the foregoingdescribed insertion depth identifying technique may have utility inother contexts, as well, and those skilled in the art will recognizethat the foregoing technique should not be limited to the contextdescribed hereinabove.

As described above, either the stabilization loop portion 680 or 680′,or the guide sheath 662 may therefore be approximated to tissuesurrounding the wound site, so as to cause spring tension against thesurrounding tissue, thereby aiding in approximately centering anintroducer about the wound site, as well as in allowing opposing sidesof the tissue surrounding the wound site to approximate one another. Itis further contemplated that alternatives of the embodiments describedabove may be implemented consistent with the invention for stretchingthe wound site and for centrally locating procedures at the wound site.For example, in the above-described embodiments, loop portions 680 and680′ provide a force to the wire and the guide sheath to spread thesheath outwardly and to approximate opposing portions of the wound site,as shown and described. However, in still other embodiments, the guidesheath can be formed having a biasing mechanism that forces the sheathinto the opened or spread position as shown in FIGS. 31 and 36. To thatend, this sheath may further comprise members on either side (such asthe wire guides or shortened variations thereof shown in the embodimentof FIGS. 20A-22A) that provide the aforementioned outwardly opposingforces on the tissue surrounding the wound site.

There are many alternatives to the foregoing description of FIGS. 27-39that will be apparent to those skilled in the art. For example, the wireforming the loop structure described herein may be provided as a singlecontinuous loop that is pre-threaded into the wire stabilization guides.In this case, the loop is closed by pulling on the free end of the loop.The wire may be snipped or cut so that it can be pulled free of thesheath and the wire stabilization guides. Other modifications may bemade. For example, the sheath may be adapted with holding mechanisms(not shown) to hold the ends of the wire in place once the doctor haspulled on the free ends to form the loop. Still other modifications maybe made. For example, instead of using wire in cooperation with thetubular wire stabilization guides to for the loop, the present inventioncontemplates that this arrangement can be replaced with a singleelongated member (e.g. similar to the wire stabilization guide describedherein) affixed to the guide sheath on opposing sides so that pullingthis member forms the loop as shown in the drawings. In other words, thewire stabilization guide and wire described above may be replaced with asingle member of sufficient modulus to for the loop as set forth herein.The wire described herein may comprise a tube, filament, strandedfilaments, or other structures that are equivalent.

Still other modifications can be made. For example the stabilizationguides have been described herein as being generally tubular so thatwire can be threaded therethrough. However, this is only an exemplaryarrangement. The stabilization guides and wire could be coupled togetherin other configuration, for example, sliding engagement that maycomprise a tongue-and-groove coupling, dovetail coupling, or otherarrangement that would permit relative motion between the stabilizationguides and the wire, while still providing mechanical strength along atleast one axis.

FIGS. 40-45 depict another exemplary embodiment of the introducer of thepresent invention. In this embodiment, the wire stabilization guides aremodified to include intralumenal support for procedures being performedat the vascular puncture site such as closure of the puncture or ananastomosis procedure. FIG. 40 depicts a similar introducer as shown inFIGS. 20-26, except in this exemplary embodiment the wire stabilizationguides 680 comprise a retention device 820 formed along a portion of theguide.

Deployment of the retention device is depicted in FIGS. 41-45. As in theprevious embodiments, the wire stabilization guides 680 are deployed bymoving the guide rod 654 with respect to the sheath 660. The retentiondevice 820 is formed along the length of the wire stabilization guide ata predetermined distance from the end of the sheath. One utility of theretention device 820 is to ensure the sheath 660 remains located on thewound site, so the predetermined distance of the retention device fromthe end of the sheath may be chosen, for example, in accordance with thethickness of the tissue in which the device is deployed. FIG. 43 depictsthe sheath and stabilization guides in a deployed position. In thisexemplary embodiment, the retention device formed on each stabilizationguide secures the sheath to the arterial wall to prevent transversemovement of the sheath with respect to the wound site.

The retention device 820 of this embodiment is essentially an expandingportion of the wire stabilization guide. To that end, FIG. 44A depictsthe retention device deployed into the expanded position. The device 820is formed by a split 822 on each side of the stabilization guide 680.The loop actuation wire is affixed to the wire stabilization guide, forexample, at point 824. To deploy the retention device, the wire (656,657) is pulled proximally, thus causing the distal end of the wirestabilization guide to be drawn proximally, and causing the retentiondevice to compress and buckle at the split sections (by placing atensile load on the stabilization guide). To release the retentiondevice, the wire is moved distally, thereby releasing tension on thestabilization guide, as shown in FIG. 45.

Returning again to FIGS. 44A and 44C, compression on the stabilizationguide to form the retention device may also be used to expand the distaltip of the sheath at the slits or weakened tear seams 686, as shown inthe relaxed position (FIG. 43B) and expanded position (FIGS. 43A and C).

FIGS. 44-48 depict yet another exemplary embodiment of the introducer ofthe present invention. This embodiment is similar to the embodiment ofFIGS. 27-34, except in this exemplary embodiment the wire stabilizationguides 680 comprise a retention device 820 formed along a portion of theguide. In this embodiment, the loop actuation wire forms a single loop,with a retention device 820 positioned on one or bothwire stabilizationguide adjacent the sheath. Other features depicted in the Figures arethe same as the previous embodiment, described above.

FIGS. 49-55 depict numerous exemplary embodiments of the retentiondevice of the present invention. FIGS. 49A and 49B depict detailed viewsof the retention device 820 of the previous embodiment in the relaxed(static) and deployed positions, respectively. In FIG. 50, the retentiondevice 820′ comprises a tubular member with a hollowed out notch portion824 formed along the length thereof. Compression of the tubular membercauses the material opposite the notch to collapse thereby forming theretention device (FIG. 50B). In FIG. 51, the retention device 820″comprises a tubular member with a plurality of filaments 826 that fold(upon compression) to form the retention device. In this case, a smallloop is formed. Alternatively, a buckle (not shown) is formed having aU-shape that does not form a complete loop. FIG. 52, retention device820′″ comprises a tubular member with generally symmetrical notches oneither side, 840 and 842, with slots eminating from the notches whichoverlap approximately midway between the notches. The slots overlapforming a through-hole approximately equal to the inside diameter of thetube. The cross section of the tube in the area of the slot is that of aU-shaped beam. Compression causes the tubular member to fold at thenotched sections 840 and 842, fulcruming on the wire at the locationwhere the slots overlap, as shown in FIGS. 52B and 52C.

FIG. 53 depicts yet another exemplary embodiment of a retention device900 that is similar to the example shown in FIG. 51, except theretention device 900 comprises a single strand member between astationary member 904 and a moveable member 906. The moveable member 906is moved over the wire guide 660 towards the stationary member 904buckling the strand, as shown in FIG. 53B. Similarly, in FIG. 55 themoveable member 906 is brought closer to the stationary member 904 toform a loop from the strand 902. In the retention device 900′ of FIG.54, the strand 902′ is disposed off-line (i.e., off axis) between thestationary member 904 and the moveable member 906 (FIG. 54A). Movementof the moveable member 906 forms a loop as shown in FIG. 54B.

In the embodiments of FIGS. 40-55, the retention device of the presentinvention may be viewed as an extension or lobe formed on one or bothstabilization guides (FIGS. 40-45), or, in the case of the loopstructure of FIGS. 46-48, the retention device may be formed on opposingsides of the loop, as shown. The retention device examples of FIGS.49-55 are intended to apply to both the embodiments of FIGS. 40-45 and46-48. The orientation of the retention device with respect to the wirestabilization guide or loop is depicted as generally perpendicularthereto, but the retention device may be formed from greater than 0degrees to less than 180 degrees from wire stabilization guide or loopand still work as intended. The present invention covers all suchalternatives. The orientation of the retention device with respect tothe wound opening is depicted, for example in FIGS. 43, 45 and 47, asbeing generally perpendicular to the long axis of the wound. However,this angle is not a requirement of the present invention, but rather theretention device can be disposed at any angle with respect to the longaxis of the wound.

Although the present invention has been described in relation toparticular embodiments thereof, many other variations and modificationsand other uses will become apparent to those skilled in the art. It ispreferred, therefore, that the present invention be limited not by thespecific disclosure herein, but only by the appended claims.

What is claimed is:
 1. An introducer comprising: a tubular sheath havingtwo wire stabilization guides, said wire stabilization guides comprisingelongated tubular members having at least a portion thereof extendingfrom an end of said sheath; a retention device formed on said portion ofsaid wire stabilization guide extending from said end of said sheath,said retention device comprising a slit on either side of said wirestabilization guide wherein compression of said retention device causessaid wire stabilization guide to expand outwardly in at least onedirection; a guide rod sized to fit within said tubular sheath andhaving two slots formed along its length, at least one slot releaseablyholding one respective said wire stabilization guide; a wire having twoends, each said end threaded into a respective said wire stabilizationguide and thus forming a loop of wire from the wire protruding from saidwire stabilization guides extending from said end of said sheath.
 2. Anintroducer, comprising: a tubular sheath having a wire stabilizationguide, said wire stabilization guide comprising an elongated tubularmember having at least a portion thereof extending from an end of saidsheath; a retention device formed on said portion of said wirestabilization guide extending from said end of said sheath, saidretention device comprising a slit on either side of said wirestabilization guide wherein compression of said retention device causessaid wire stabilization guide to expand outwardly in at least onedirection; a guide rod sized to fit within said tubular sheath andhaving a slot formed along its length, said slot releaseably holdingsaid wire stabilization guide; a wire having two ends, one end threadedinto said wire stabilization guide, the other end attached to said guidesheath, and thus forming a loop of wire from the wire protruding fromsaid wire stabilization guide extending from said end of said sheath.